Z-1947-2013Class II

1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005...

Name: Z-1947-2013 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005...
Creator: Carefusion 2200 Inc
Published: 2013-04-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-04-22 / Terminated / root cause: manufacturing process

FDA source

Carefusion 2200 Inc began a recall of 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask... on 2013-04-22. FDA classified it as Class II and gives the reason as "CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1947-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-22
Posted: 2013-08-13
Terminated: 2015-06-16
Recalling firm: Medtronic, Inc.
Product: 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: CareFusion sent an URGENT RECALL NOTICE letter dated April 22, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to complete and return an attached Distributor Acknowledgement Form within fifteen (15) days of receipt indicating their acknowledgement of the URGENT RECALL NOTICE and indicate if they have any affected product on hand. They are further requested to perform a 100% physical inventory to verify if any of the affected product codes/lot numbers are in stock within their distribution network/facility. In addition, customers are requested to forward the Customer Acknowledgement Form, the Customer Notification Letter, the Certificate of Destruction Form, the Pictures of Location of Lot Numbers on Case/Product, and the Frequently Asked Questions (FAQs) to all end users which they have distributed the affected product. For questions call 847-473-7097.
Quantity in commerce: 14,112 units
Distribution: US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA
Product codes and lots: 1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668; 2) Product Code 2K8004; Lot Number: 0000355673; 3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677; 4) Product Code 2K8034; Lot Number: 0000355688; 5) Product Code 2K8035; Lot Number: 0000358023; 6) Product Code 2K8037; Lot Number: 0000358025; 7) Product Code 2K8040; Lot Number: 0000358026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1947-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-13

Product code BTM

K924610Class IIBaxter Adult/pedi/infant Single Use Man ResuscitEngineered Medical Systems / cleared 1993-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)